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510(k) K812129

COAT-A-COUNT DIGITOXIN RIA KIT by Diagnostic Products Corp. — Product Code DPG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

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  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
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  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code DPG

  • K935229 — OPUS DIGITOXIN (December 22, 1993)
  • K780075 — RIALYZE DIGOXIN (February 28, 1978)